Are the wheels coming off the plan to import drugs from Canada, just days after FDA approved Florida’s import plan? It appears that Canada is not too happy and will take any action necessary to assure that importation of drugs by one of the biggest states in the United States will not disrupt the Canadian drug supply. The “Statement from Health Canada on FDA decision on Florida bulk drug importation plan” (here) issued on January 8, 2024, makes their fear abundantly clear.

If Canada is that worried about Florida, how high do you think the hair on the back of their neck will stand if another even larger state’s plans are also approved by the FDA (for example, Texas or California)? The Canadian statement reads in part: “Regulations have been implemented under the [Canadian] Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada. This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida’s bulk importation plan, or any other U.S. state’s future importation programs.”

So, it looks like Florida’s battle to get FDA’s OK for its import program, which took several years (see previous post here) to review and approve, will now be met with a resolute Canadian position that could derail the Florida plan before it imports the first drug from across the border!  

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Robert Pollock, M.S., is Senior Advisor, Outside Director to the Board at Lachman Consultants. He joined Lachman Consultants following a distinguished career with the FDA and the Public Health Service. His FDA experience, culminating as the Acting Deputy Director of the Office of Generic Drugs, enables him to provide expert advice and assistance on all aspects of FDA and Regulatory filings. Mr. Pollock is well-versed in the intricacies of International Harmonization Issues, regulatory strategies, standards and filing issues, resolution of FDA regulatory matters, as well as in the resolution of patent/exclusivity issues.